ACRIN 6666 Therapeutic Surgery Form

Transcription

1 S1 ACRIN 6666 Therapeutic Surgery Form 6666 Instructions: Complete a separate S1 form for each separate area of each breast excised with the intent to treat a cancer (e.g. each lumpectomy or mastectomy). May be completed by study RA or study Radiologist; original pathology report should be submitted. Lymph nodes excised on the same date as the breast treatment surgery can be reported on the same S1 form as the main breast surgery. If an axillary dissection is performed at a later date, or re-excision of margins is performed, please complete a separate form S1. 1. Is participant known to have distant metastases from breast cancer? (proceed to Q1a) (detail then proceed to Q1a) Primary Cancer was in: o Right breast o Left breast o Both breasts 1a. Has an S1 form previously been submitted for this breast? 1b. Was therapeutic surgical procedure performed? ; If no, specify reason from code table (proceed to Q11) 2. Date of treatment surgery (mm-dd-yyyy) - - 2a. Name of facility where surgery performed 2b. Time point in study when this cancer was detected? For revised or corrected form check box and fax to Code Table for Q1b 1 Not indicated (other medical problems) 2 Participant refusal 3 Participant did not return 4 Unable to be performed and rescheduled 5 Other o Initial screening o 6 month follow-up o 12 month screening o 18 month follow-up o 24 month screening o 30 month follow-up o 36 month follow-up o Other, specify cancer known preoperatively this breast 3. What surgery was performed? 3a. Tumor Excision o Single lumpectomy o Double lumpectomy o Quadrantectomy/ Wide excision/segmentectomy o Mastectomy o Prophylactic mastectomy o Other, specify o Already performed, reported previously (on prior S1 form) 3b. Lymph node evaluation Sentinel Node(s) t done (proceed to Q3c) o Already performed, reported previously (on prior S1 form, proceed to Q3c) o Performed (complete) Number of nodes retrieved Number malignant Check if micrometastasis (< 2 mm) only by (detail) o IHC o H + E o Both 3c. Axillary dissection t done (proceed to Q4) o Performed (complete) Number of nodes retrieved Number malignant Check if extracapsular invasion 6666 S of 6

2 4. Pathology Specimen ID# 4a. Were slides sent for central review and results obtained? (proceed to Q5) (complete Q4b) o Pending (proceed to Q5) 4b. Did central review change management? (proceed to Q5) (complete) Local result Central result (reference code table) o Upgrade from o Downgrade from to to Code Table for Q4b (upgrade/downgrade) 1 Benign (other than below) 2 Papilloma 3 Possible phyllodes 4 Radial scar/complex sclerosing lesion 5 ADH 6 ALH or LCIS 7 Atypical papillary lesion 8 DCIS 9 Invasive Cancer 5. How many previously enumerated lesions were excised with this surgical specimen (i.e. lumpectomy or mastectomy)? 5a. Lesion Location Check if this lesion ONLY seen on MRI from Nipple (largest dimension) e.g. 7:00 = 0700, 12:30 = 1230) o axilla OR o retroareolar o R o L o' clock o central 5b. Was there another previously enumerated lesion removed from this breast during this surgery? (proceed to Q6) (proceed to Q13) 6. Final Margin Status (check all that apply) Margins clear o 10 mm or more o 4-9 mm o 1-3 mm o < 1 mm Margins equivocal Invasive tumor at margin DCIS at margin Not applicable, no cancer found 7. Will additional surgery be needed for this breast or axilla (other than cosmetic surgery)? (please complete another S1 when performed) 6666 S of 6

3 8. Final Histopathology 8a. Is cancer present at excision? (complete Q8b-9d based on core information) o Felt to have been excised at core o S/P neoadjuvant chemotherapy o Felt to have been missed by surgeon or pathologist o Prophylactic mastectomy (skip to Q12) (complete Q8b-9d based on worst applicable information from combination of core and excision) 8b. Are multiple tumors present? o Multifocal (< 4 cm apart) o Multicentric (> 4 cm apart) o Diffuse throughout breast 8c. Is invasive cancer present? (proceed to Q9) (provide largest diameter) mm Largest diameter of invasive component (per pathology report) (code 999 if unknown or not reported) 8g. What is the ER status? o Positive o Negative t assessed What is the PR status? o Positive o Negative t assessed What is the Her-2/neu (c-erb2) status? o Negative o 1 + o 2 + o 3 + t assessed 9. Is Ductal Carcinoma in situ present? (proceed to Q10) (proceed to Q9a) (proceed to Q10) 8d. Is there lymphovascular invasion? 8e. Detail invasive cancer (check all that apply) Invasive ductal carcinoma (complete grade and pattern) Grade o Grade cannot be assessed o Low (Grade I) o Intermediate (Grade II) o High (Grade III) o Insufficient specimen Pattern(s) Tubular Colloid/ mucinous Medullary Cribriform Micropapillary NOS Unknown Other, specify Invasive lobular carcinoma Invasive with mixed ductal/lobular features Invasive, not of breast origin, (specify and then STOP, sign form ) 8f. Were Receptors done? (proceed to Q9) (detail then proceed to Q8g) o From core biopsy o From surgical specimen (proceed to Q9) 9a. Grade o Grade cannot be assessed o Low (Grade I) o Intermediate (Grade II) o High (Grade III) o Insufficient specimen 9b. Is central necrosis present? 9c. Histologic type(s) Number of slides with DCIS Total number of slides (code 99 if unknown) (code 99 if unknown) 9d. Extensive Intraductal component (invasive cancer and DCIS where DCIS is at least 25% of tumor with additional DCIS foci outside main tumor mass) 10. Were all pathologically proven cancers in this breast identified on either mammography or US preoperatively? (Note: A cancer found only on second look mammography or US after MRI would be classified as not identified on mammography or US.) (detail) Number of additional malignant foci: (code 99 if unknown) (Detail below. Note: code mixed invasive and intraductal as invasive) o Invasive ductal carcinoma o Invasive lobular carcinoma o Invasive with mixed ductal/lobular features o DCIS only o Invasive, not of breast orgin (proceed to Q11) (proceed to Q11) 6666 S of 6

4 11. TNM Stage 11a. Has staging already been reported on another S1? (proceed to Q11c) 11b. Did the results of this surgery change the staging of this cancer? (proceed to Q12) (proceed to Q11c) 11c. T Stage (Primary Tumor) o TX Primary Tumor cannot be assessed Reason o T0 No evidence of primary tumor o Tis Ductal carcinoma in situ o T1 Tumor 2 cm or less in greatest dimension o T1 mic Microinvasive tumor, < 0.1 cm in greatest diameter o T1a Invasive tumor, 0.1 < x < 0.5 cm in greatest diameter o T1b Invasive tumor, 0.5 < x < 1.0 cm in greatest diameter o T1c Invasive tumor, 1.0 < x < 2.0 cm in greatest diameter o T 2 Invasive tumor, 2.0 < x < 5.0 cm in greatest diameter o T3 Invasive tumor, > 5 cm in greatest diameter o T4 Tumor of any size with: o Direct extension to chest wall, T4a o Direct extension to skin with edema (including peau d' orange) or ulceration of skin of the breast or satellite skin nodules confined to the same breast, T4b o Both skin and chest wall extension, T4c o Dermal lymphatics involved, inflammatory cancer, T4d 11d. N Stage (Regional Lymph Nodes) o NX Regional lymph nodes cannot be assessed (e.g., previously removed) o N0 No regional lymph node metastasis o pn0 No regional lymph node metastasis histologically, no additional examination for isolated tumor cells (ITC) (3) o pn0(i-) No regional lymph node metastasis histologically, negative IHC o pn0 (i+) No regional lymph node metastasis histogically, positive IHC cluster greater than 0.2 mm o N1 Metastasis in moveable ipsilateral lymph node(s) o pn1mi Micrometastasis (greater than 0.2 mm, none greater than 2.0 mm) o pn1a Metastasis in 1 to 3 axillary lymph nodes o pn1b Metastasis in internal mammary nodes with microscopic disease detected by sentinel lymph node dissection but not clinically apparent (5) o pn1c Metastasis in 1 to 3 axillary lymph nodes and in internal mammary lymph nodes with microscopic disease detected by (5, 6) sentinel lymph node dissection but not clinically apparent o N2 Metastases in ipsilateral axillary lymph nodes fixed or matted, or in clinically apparent (1) ipsilateral internal mammary nodes in the absence of clinically evident axillary lymph node metastasis o N2a Metastasis in ipsilateral axillary lymph nodes fixed to one another (matted) or to other structures o N2b Metastasis only in clinically apparent (1) ipsilateral internal mammary nodes and in the absence of clinically evident axillary lymph node metastasis o pn2 Metastasis in 4-9 axillary lymph nodes, or in clinically apparent (1) internal mammary lymph nodes in the absence of axillary lymph node metastasis o pn2a Metastasis in 4-9 axillary lymph nodes (at least one tumor deposit greater than 2.0 mm ) o pn2b Metastasis in clinically apparent (1) internal mammary lymph nodes in the absence of axillary lymph node metastasis o N3 Metastasis in ipsilateral infraclavicular lymph node(s) with or without axillary lymph node involvement, or in clinically apparent (1) ipsilateral internal mammary lymph node(s) and in the presence of clinically evident axillary lymph node metastasis; or metastasis in ipsilateral supraclavicular lymph node(s) with or without axillary or internal mammary lymph node involvement o N3a Metastasis in ipsilateral infraclavicular lymph node(s) and axillary lymph node(s) o N3b Metastasis in ipsilateral internal mammary lymph node(s) and axillary lymph node(s) o N3c Metastasis in ipsilateral supraclavicular lymph node(s) o pn3 Metastasis in 10 or more axillary lymph nodes, or in infraclavicular lymph nodes, or in clinically apparent (1) ipsilateral internal mammary lymph nodes in the presence of 1 or more positive axillary lymph nodes; or in more than 3 axillary lymph nodes with clinically negative microscopic metastasis in internal mammary lymph nodes; or in ipsilateral supraclavicular lymph nodes o pn3a Metastasis in 10 or more axillary lymph nodes (at least one tumor deposit greater than 2.0 mm), or metastasis to the infraclavicular lymph nodes o pn3b Metastasis in clinically apparent (1) ipsilateral internal mammary lymph nodes in the presence of 1 or more positive axillary lymph nodes; or in more than 3 axillary lymph nodes and in internal mammary lymph nodes and in internal mammary lymph nodes with microscopic disease detected by sentinel lymph node dissection but not clinically apparent (5) o pn3c Metastasis in ipsilateral supraclavicular lymph node(s) 11e. M Stage (Distant Metastasis) o MX Presence of distant metastasis cannot be assessed o M0 No evidence of distant metastasis o M1 Distant metastasis (includes metastasis to ipsilateral supraclavicular lymph node(s) Foot Notes (next page) 6666 S of 6

5 Foot Notes 1. Clinically apparent is defined as detected by imaging studies (excluding lymphoscintigraphy) or by clinical examination. 2. Classification is based on axillary lymph node dissection with or without sentinel lymph node dissection. Classification based solely on sentinel lymph node dissection without subsequent axillary lymph node dissection is designated (sn) for "sentinel node," e.g., pn0 (i+) (sn). 3. Isolated tumor cells (ITC) are defined as single tumor cell or small cell clusters not greater than 0.2 mm, usually detected only by immunohistochemical (IHC) or molecular methods but which may be verified on H&E stains. ITCs do not usually show evidence of metastatic activity (e.g., proliferation or stromal reaction.) 4. RT-PCR: reverse transcriptase/polymerase chain reaction. 5. Not clinically apparent is defined as not detected by imaging studies (excluding lymphoscintigraphy) or by clinical examination. 6. If associated with greater than 3 positive axillary lymph nodes, the internal mammary nodes are classified as pn3b to reflect increased tumor burden. 7. T1 includes T1mic 12. Will another form S1 be completed for this breast at this time (e.g. double lumpectomy)? Comments: STOP: Sign and date form - - Signature of person responsible for the data Date Form Completed (mm-dd-yyyy) Signature of person entering data on web 6666 S of 6

6 13. Detail additional enumerated lesion this specimen 13a. Lesion Location Check if this lesion ONLY seen on MRI from Nipple (largest dimension) e.g. 7:00 = 0700, 12:30 = 1230) o axilla o R o L o' clock OR o retroareolar o central 13b. Was there another previously enumerated lesion removed from this breast during this surgery? (proceed to Q6) (proceed to Q14) 14. Detail additional enumerated lesion this specimen 14a. Lesion Location Check if this lesion ONLY seen on MRI from Nipple (largest dimension) e.g. 7:00 = 0700, 12:30 = 1230) o axilla o R o L o' clock OR o retroareolar o central 14b. Was there another previously enumerated lesion removed from this breast during this surgery? (proceed to Q6) (proceed to Q15) 15. Detail additional enumerated lesion this specimen 15a. Lesion Location Check if this lesion ONLY seen on MRI e.g. 7:00 = 0700, 12:30 = 1230) from Nipple o axilla o R o L o' clock OR o retroareolar o central (largest dimension) Proceed to Q S of 6